Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction

January 11, 2010 updated by: University of Calgary

Comparison of Home Vs. Physiotherapy-Supervised Rehabilitation Programs Following Reconstruction of the Anterior Cruciate Ligament (ACL)

This study was designed to determine whether or not there were any differences in knee range of motion, both statically and during gait, sagittal plane knee laxity, and quadriceps and hamstrings strength in patients three months post-ACL reconstruction with a bone-patellar tendon-bone autograft based on their performance of a primarily home based rehabilitation program or a standard physiotherapy-supervised program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary Sport Medicine Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 16 years of age or older
  2. Surgery at least 6 weeks after injury to allow for a return of full range of motion, minimize swelling, and offset strength deficits due to pain/swelling14,28
  3. ACL reconstruction with a bone-patellar tendon-bone autograft

Exclusion Criteria:

  1. Previous or concomitant reconstruction of any knee ligament to either knee
  2. Ongoing knee abnormality unrelated to the ACL injury (eg, evidence of changes on radiographs consistent with osteoarthritis)
  3. Professional athletes or workers' compensation patients
  4. Complications during surgery (eg, inadequate graft fixation requiring protocol modification)
  5. Patients without access to local physical therapy services

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Home-based
Home-based post-operative rehabilitation program with 4 scheduled physiotherapy sessions over the first 3 post-op months
Procedure: Home-based rehabilitation program
Home-based rehabilitation program that includes 4 physiotherapy sessions in the first 3 post-op months
ACTIVE_COMPARATOR: Physiotherapy supervised
Physiotherapy-supervised rehabilitation program including 17 scheduled physiotherapy sessions in the first 3 post-op months
Procedure: Physiotherapy-supervised rehabilitation program
Physiotherapy-supervised rehabilitation program that includes 17 scheduled physiotherapy sessions in the first 3 post-op months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Active assisted knee flexion and passive knee extension range of motion
Time Frame: pre-op, 6 & 12 weeks post-op
pre-op, 6 & 12 weeks post-op

Secondary Outcome Measures

Outcome Measure
Time Frame
Knee flexion and extension range of motion during gait
Time Frame: pre-op, 6 & 12 wks post-op
pre-op, 6 & 12 wks post-op
Sagittal plane laxity of the knee
Time Frame: pre-op, 6 & 12 wks post-op
pre-op, 6 & 12 wks post-op
Isokinetic quadriceps and hamstrings strength
Time Frame: pre-op and 12wks post-op
pre-op and 12wks post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

AirCast LLC
Calgary Health Region
Olympic Oval Endowment Fund
Fitter International Inc.

Investigators

  • Principal Investigator: Nicholas G. Mohtadi, MD, MSc, University of Calgary Sport Medicine Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Primary Completion (ACTUAL)

February 1, 2001

Study Completion (ACTUAL)

February 1, 2001

Study Registration Dates

First Submitted

November 26, 2007

First Submitted That Met QC Criteria

November 26, 2007

First Posted (ESTIMATE)

November 28, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10339

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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